Eti-Ea-G Assay
FDA 510(k) K992191 · DiaSorin, Inc.
510(k) numberK992191
Submission
- Device name
- Eti-Ea-G Assay
- Applicant
- DiaSorin, Inc.
Columbia, MD, US - Received
- June 28, 1999
- Decision date
- July 12, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
Device classification
- Product code
- LSE – Epstein-Barr Virus, Other
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3235
- Specialty
- Microbiology
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Questions and answers
When was Eti-Ea-G Assay cleared by the FDA?
Eti-Ea-G Assay (K992191) received a 510(k) decision of Substantially Equivalent on July 12, 1999, 14 days after the submission was received.
What is the product code of K992191?
The FDA product code is LSE – Epstein-Barr Virus, Other, a Class I (low risk) device regulated under 21 CFR 866.3235.